Kepivance Reduces Toxicity of High-dose Therapy for Multiple Myeloma

Among patients undergoing high-dose therapy and autologous stem cell transplantation for multiple myeloma, a three-day short course of Kepivance® (palifermin) reduces the toxicity of treatment. These results were published in the Annals of Oncology.

Multiple myeloma is a cancer of plasma cells. Plasma cells are a special type of white blood cell that are part of the body’s immune system. Plasma cells normally live in the bone marrow and make proteins, called antibodies, which circulate in the blood and help fight certain types of infections. Plasma cells also play a role in the maintenance of bone by secretion of a hormone called osteoclast activating factor, which causes the breakdown of bone. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. These abnormal antibodies are referred to as paraproteins or monoclonal proteins in the blood (M proteins) or urine (Bence Jones protein).

Treatment of multiple myeloma may include high-dose therapy followed by autologous stem cell transplantation. Among other side effects of high-dose therapy, patients may experience oral mucositis (inflammation of the lining of the mouth and throat). The severity of oral mucositis can vary, ranging from redness and irritation to sores and severe pain that interfere with swallowing.

Kepivance is a keratinocyte growth factor that has been shown to reduce the incidence and severity of oral mucositis in patients undergoing high-dose therapy prior to a stem cell transplant.

The current Phase II study, conducted in Germany, involved 67 patients with multiple myeloma receiving high-dose melphalan followed by autologous stem cell transplantation.[1] All patients received Kepivance for three days before high-dose therapy.

Compared with historical controls (patients who were treated in the past without Kepivance), patients who received Kepivance had shorter hospitalizations and were less likely to require a feeding tube. Patients who received Kepivance were also less likely to require narcotic pain medications or red blood cell transfusions. These benefits of Kepivance were observed among patients with normal kidney function. Patients with poor kidney function tended to have high rates of severe mucositis in spite of treatment with Kepivance.

This study further documents the effectiveness of Kepivance in preventing oral mucositis in the stem cell transplant setting.